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See No Evil, Do No Evil, Do Nothing

Dan Flynn’s “Inspected by USDA” in Food Safety News last month was a particularly thought-provoking editorial, to which I have some responses.

USDA’s two legal losses stemming from its actions at Supreme Beef (SB) in late 1999 should have exposed a fatal flaw in USDA-Style HACCP, causing the agency to revise its allegedly “science based” meat inspection system.

USDA withdrew inspectors from Supreme Beef subsequent to the company’s failure in 3 consecutive Salmonella test sets. Supreme Beef eventually won the legal battle, but lost the war, as it experienced bankruptcy. Therefore, USDA won the war, but forgot the lessons provided by the battle. Two superlative sources describing the findings from the U.S. District Court for the Northern District of Texas can be found at:

Before I quote from some of these legal conclusions, let me briefly explain what I consider to be the agency’s primary failure of the Salmonella Performance Standards. Supreme Beef (SB) did not slaughter, but merely purchased meat from source slaughter providers. When this meat was ground at SB, and tested, the incidence of Salmonella ranged from 20.8 percent to 47 percent, clearly a hazard to public health. To save face, USDA/FSIS withdrew inspectors from SB.

We must remember that Salmonella is an “enteric” bacterium, which by strict definition means the bacteria emanates from within animals’ intestines, and by extension flourish on manure-covered hides, both of which are found in slaughter plants, but not at downstream further processing plants such as SB.

FSIS must realize by now that its closure of SB has NOT benefitted public health, as proven by the plethora of ongoing outbreaks and recurring recalls that have become a common occurrence in contemporary America. Why? Because FSIS focuses its enforcement actions (actually RE-actions) almost exclusively at the downstream DESTINATION facilities, instead of at the source slaughter providers. This intentional agency oversight is designed to facilitate comfort at the agency, which has degenerated into a semi-retirement role at the industry’s biggest plants, gratis USDA-style HACCP.

When FSIS introduced its version of HACCP, almost no one realized the agency had dramatically changed Pillsbury-style HACCP into a perverted imposter, while maintaining the HACCP name. Consumers continue to pay the price for this intentional bait and switch. While introducing USDA-style HACCP, the agency promised that its role under HACCP would include:

1.The agency would assume a “hands off” role.

2.The agency would no longer police the industry, but the industry would police itself.

3.The agency would disband its previous command and control authority.

4.Each plant would write its own HACCP Plan, and the agency can’t tell the plant what must be in its HACCP Plan.

In retrospect, FSIS has been fully compliant with the above four promises … but only at the largest industry giants. In sharp contrast, FSIS regularly ignores these promises at small plants, which are far easier enforcement prey.

In a Frontline TV program entitled “Modern Meat,” which aired on April 18, 2002, Elsa Murano stated: “The HACCP system does not give the plants any authority. Responsibility. The authority is ours. We are the ones with authority. We shut down plants all the time. Um, last year alone we took about 200 enforcement actions, uh, in plants in the United States. So, we very much have the authority to do that. Um, our inspectors have the authority to do … to follow the regulations and to enforce them on a daily basis.”

Plants which are closing are small plants, not the industry’s giants. It appears as though the plants the agency is shutting down are the wrong plants. If small, downstream further processing plants are the problem, and FSIS is aggressively shuttering those noncompliant small plants, why do we continue to experience outbreaks and recalls?

Supreme Beef purchased all its meat from source slaughter providers. All this meat arrived at SB marked with the official USDA Mark of Inspection, which states “USDA Inspected and Passed.” Indeed, this means that the agency intentionally allows the source slaughter plants to ship into commerce meat that is laced with Salmonella. When the Salmonella is detected at downstream further processing plants, the agency responds by unleashing its full enforcement fury at the victimized downstream plant, while insulating the source slaughter plant from accountability. FSIS is fully cognizant of this intentional oversight, and it cost the agency the SB litigation. Since the agency has failed to implement meaningful changes in its HACCP regulations, this same scenario continues to play itself out in agency/plant relations, and consumers continue to be sickened (some die).

FSIS displays the same short-sightedness with E.coli 0157:H7. The agency allows source slaughter plants to ship into commerce intact cuts of meat that are surface-contaminated with E.coli 0157:H7. FSIS blithely states that such E.coli are NOT adulterants. But when the destination facility further processes the intact cuts, the heretofore harmless bacteria supernaturally morph into killer pathogens, then are classified by FSIS as “adulterants.” Sometimes science is stranger than fiction.

Some of the more pertinent quotes from the District Court legal rulings include the following:

From paragraph 19: 47 percent of agency samples collected at SB were positive for Salmonella.

From paragraph 20: In subsequent FSIS sampling, 20.8 percent of the tests were positive for Salmonella. Supreme Beef countered that only 7.5 percent of their tests, conducted on companion parallel samples, were positive for Salmonella. “Only” 7.5 percent! That’s fine, as long as my family doesn’t eat the 7.5 percent.

From paragraph 45: “The district court agreed with Supreme and reasoned that because the USDA’s performance standards and Salmonella tests do not necessarily evaluate the conditions of a meat processor’s establishment, they cannot serve as the basis for finding a plant’s meat adulterated under Section 601 (m) (4). The district court therefore held that the examination of a plant’s end product is distinct from conditions within the plant.”

From paragraph 46: “Since we are persuaded that the Salmonella performance standard improperly regulates the Salmonella levels of incoming meat (emphasis added) and that Salmonella cross-contamination cannot product may be rendered injurious to health, we conclude that the Salmonella performance standard falls outside of the ambit of Section 601 (m) (4).”

From paragraph 49: “The use of the word ‘rendered’ in the statute indicates that a deleterious change in the product must occur while it is being ‘prepared, packed or held’ owing to insanitary conditions.”

The entire report is fascinating reading, and continues to emphasize that the agency inappropriately focused on SB’s production of finished product containing Salmonella, totally ignoring the fact that the Salmonella was arriving on incoming loads of meat, coupled with the fact that FSIS did not prove that SB’s plant was insanitary. Today, in 2010, FSIS continues to place an inappropriate focus on finished product testing, virtually dismissing the evidence that Salmonella contamination of meat occurs at the source originating slaughter plant, NOT at the downstream further processing establishment.

On page 19 of the National Provisioner dated January 2002, an ad by Surebeam included the following statement: “A performance standard is valid only if it measures the performance of the establishment itself … Microbiological testing, including pathogen testing, may be used as an indicator of an establishment’s performance, but it is only one factor to be considered in judging performance”. FSIS has yet to learn this valuable lesson.

The July 10, 2000 edition of Food Chemical News, discussing the SB litigation, stated that: “In a landmark court ruling in May, the US District Court for the Northern District of Texas prohibited USDA from concluding that grinding plants are insanitary or that their products are adulterated based on Salmonella test results (Supreme Beef Processors Inc. v. USDA). Nevertheless, Supreme says, [FSIS Administrator Tom] Billy said in a recent sworn statement that a facility which fails to control and prevent or reduce pathogens is operating under insanitary conditions, and that Supreme’s failure to control pathogens could result in product that is unwholesome, unfit for human consumption, and injurious to health. The company [SB] argues that those comments show that Billy and the agency are ignoring the judge’s decision in the case and could take extreme action against the company based upon the government’s continued belief that Supreme Beef’s plant is insanitary based solely on the test results (emphasis added).”

Personal note: This again reveals that the agency quietly endorses the right of large source originating slaughter plants to ship pathogens into commerce, and that the sole responsibility to (a) detect and (b) remove the pathogens rests upon the downstream further processing facility. Interestingly, neither the agency nor the source slaughter plant was capable of (a) detecting and (b) removing the pathogens at the SOURCE. Apparently, downstream plants have a divine ability to detect these invisible pathogens, and if they don’t, the full fury of FSIS’ enforcement actions descends upon these allegedly negligent downstream plants. Nothing has changed in the agency’s perception of reality during the 10 years subsequent to the FSIS/Supreme Beef fiasco.

The question remains whether the agency has authority to implement enforcement actions, including removal of inspectors, when insanitary conditions are observed at plants. An article in the Feb. 20, 2003 Food Chemical News reported on a settlement between USDA and Nebraska Beef, in which a federal judge stopped the agency from shuttering the Omaha, NB plant by issuing a temporary restraining order. The article stated: “USDA wanted to close the plant because of its repeated failure to correct and implement changes in its HACCP plan. In September and December of 2002, the department had twice suspended operations at the facility. Steven Cohen, spokesman for FSIS, told Food Chemical News earlier this month that the main reason the agency settled with the company was to eliminate the possibility that the plant could continue to operate under allegedly unsanitary conditions during months of litigation” (emphasis added).

Finally, the truth from an agency official: FSIS lacks the ability to shutter a plant, well, at least a larger plant.

Subsequent to ConAgra’s 19.1 million lb. recall of meat potentially contaminated with E.coli in June, 2002, USDA’s Office of Inspector General (OIG) conducted a thorough investigation. Some verbatim statements from OIG’s report 1 year later included the following:

“Data was available to both ConAgra and USDA in the period prior to the recall that indicated that E.coli contamination was becoming a continuous (emphasis added) problem at ConAgra”

“Although animal feces on product was repeatedly (emphasis added) observed during production at ConAgra, USDA took no enforcement action.”

“Although inspectors at ConAgra raised concern to their supervisors regarding the increasing level of fecal contamination and positive testing results, we (OIG) could find no evidence that USDA managers responded to the concerns raised. Supervisors were not always responsive to the inspectors’ concerns relating to increasing levels of fecal contamination.”

These statements reveal the fact that FSIS lacked the ability to implement meaningful enforcement actions, even though it observed continuous production of fecal-contaminated carcasses at ConAgra. When one branch of USDA (OIG) publicly reveals this ugly truth, we know for a fact that USDA-Style HACCP has eviscerated the agency of meaningful authority … at big plants … by intentional agency design.

Carole Sugarman wrote an article in Food Chemical News on Nov. 14, 2003, in which she discussed a speech given by then-FSIS Administrator Dr. Garry McKee to a conference of FSIS circuit supervisors, district managers, and deputy district managers in Nashville, TN. Some statements included:

“McKee said he is tired of reading articles that quote inspectors as saying they don’t have the authority to take action against a plant that’s violating its own HACCP plan or FSIS regulations.”

“McKee continued to hammer the point home. ‘Once and for all, we must bury this notion that we do not have enough authority or we are not accountable for public health,’ he said. ‘Those who do not believe this, or do not act on our given authority, will be held accountable from here on out.’ “ Yes, it’s the inspectors’ fault. Yeah, right.

“Lastly, McKee said that inspectors must know how to ask for help if they are uncertain about what course of action to take, and he told the supervisors they must provide that empowerment.”

Apparently, McKee had not read OIG’s report of the ConAgra debacle. A close study of his entire speech reveals that McKee placed blame for USDA’s shortcomings on allegedly incompetent inspectors, who had actually been emasculated by USDA-Style HACCP.

As food safety problems have emerged, and inspectors and food safety activists have pressed for common sense changes to the agency’s HACCP Hoax, the agency’s persistent response has been “Let HACCP work.” Well, HACCP has now been in existence at the biggest plants for almost 13 years. It should be fairly mature by now, but outbreaks and recalls remain persistent enemies, with no evidence of abatement, so what has gone wrong? Answer: USDA-style HACCP is not working.

Pillsbury’s HACCP plan was designed for cooked, ready-to-eat food, such as used by NASA and the Army. Such products were consistently safe. Pillsbury’s HACCP system was designed as a voluntary program. In sharp contrast, USDA-style HACCP is mandated for all federally inspected plants. And, USDA requires HACCP for raw meat and poultry, which is not r
eady-to-eat.

FSIS totally ignores the self-evident truth that raw meat and poultry cannot be pathogen-free in the absence of a kill step, such as provided by full cooking or irradiation. Because products produced under Pillsbury-style HACCP are consistently safe, product testing is not required, and deregulation is appropriate.

Dr. William Sperber is a microbiologist who worked for Pillsbury from 1972 – 1995, fine tuning Pillsbury’s HACCP protocol into a superb scientific marvel. Dr. Sperber authored an article in the December 2009/January 2010 edition of Food Safety Magazine entitled “Happy 50th Birthday to HACCP.” Unbeknown to most of us, HACCP has been around for 50 years, and only recently introduced (and greatly revised) by FSIS. Two of Dr. Sperber’s concluding remarks included the following:

“HACCP is a preventative system to control significant, identified hazards.”

“It [HACCP] does not rely on product testing or lot acceptance criteria.”

Both of Dr. Sperber’s conclusions are 180 degrees opposite of USDA-style HACCP. Because FSIS prefers to conduct sampling/testing as close to the consumer as possible (and as far away from the source slaughter plant as possible), the agency is relegated to a reactionary stance, rather than preventative. FSIS waits for outbreaks to occur, then commences a search for a downstream further processing plant against which all agency enforcement actions can be assessed.

If the agency is successful, it can then repeat Elsa Murano’s statement that the agency closes plants all the time (only small plants, of course). To date, FSIS monolithically opposes tracebacks to the source of contamination, i.e., source-originating slaughter plants, when detecting E.coli & Salmonella in commerce. The agency merely reacts, by forcing victimized downstream entities to implement corrective actions to prevent recurrences.

As such, FSIS dismisses the GIGO effect (Garbage in, Garbage Out). FSIS has been paralyzed with fear of litigation from the large source slaughter plants if the agency were ever audacious enough to trace back to the source of contamination and attempt meaningful enforcement actions at the source. The agency remembers its litigation losses against Supreme Beef and Nebraska Beef, neither of which are members of the Big Four packers, which slaughter 88 percent of our feedlot steers and heifers.

Sperber’s second conclusion above appears to be sacrilegious in today’s meat environment, realizing the incidence of pathogen-laced meat and outbreaks. We must remember that USDA-style HACCP belongs in a different galaxy than Pillsbury’s HACCP protocol. Since USDA mandates its HACCP Hoax on all raw meat & poultry plants, a sizeable amount of microbial sampling is imperative. Pillsbury-style HACCP products need little if any testing, because they are consistently safe. Admittedly, current meat plants which produce RTE products may function very well under the HACCP ideal, because they produce meat products that have been exposed to a kill step.

Bottom line: true HACCP does not require microbial testing. But USDA-style HACCP is not truly HACCP.

FSIS policy makers did, however, succeed in one of their objectives when the agency implemented HACCP. All command and control was indeed removed from in-plant inspectors. But it was not removed from the agency as initially promised. Instead, command and control has been firmly entrenched in FSIS district offices and in DC, where bureaucrats make daily decisions from their remote locations, separated by time and space from actual plant operations. Countless numbers of small plant owners have become aware of this agency bait-and-switch ruse, as evidenced by agency enforcement actions against victimized downstream plants

The value of the official USDA Mark of Inspection has also been questioned, as the agency voluntarily bequeathed its previous police ability over to the industry, has embraced a “hands off” non-involvement role, and allegedly jettisoned its command and control authority.

In June 2008, USDA sent a PowerPoint presentation to its field force for training purposes. The title of the PowerPoint was “Prerequisite Programs for E.coli 0157:H7.” The headline on the top of slide 2 of the PowerPoint says “BASIC PRINCIPLES.” The next sentence stated “Grinders with prerequisite programs should not rely on the mark of inspection to accept incoming product.”

As incredulous as this agency admission is, we must congratulate the agency for its refreshing candor in admitting the Mark of Inspection is valueless. FSIS redoubled its disclaimer in FSIS Notice 05-09, dated Jan. 7, 2009, in which it stated in Section II (A): “An establishment that receives, grinds, or otherwise processes raw beef products cannot conclude that E.coli 0157:H7 is not reasonably likely to occur in its production process because the product it receives bears the mark of inspection.” Therefore, consumers should have NO confidence that USDA inspected and passed meat is wholesome. This is yet another reason that USDA invests substantial funds to educate consumers, because the Mark of Inspection has lost all pertinence under USDA-style HACCP.

However, the new FSIS leadership team of Obama/Vilsack/Hagen/Almanza/Engeljohn may well constitute the first viable team at the top since the rollout of the FSIS HACCP Hoax in the mid-90s. In a Sept 23, 2010 speech at the National Food Safety Conference, Dr. Elisabeth Hagen, the new USDA Under Secretary for Food Safety, made numerous statements that presage a new leadership attitude at the agency.

Hagen strongly endorsed prevention, while admitting the agency has spent too much time on reaction in the past. She also referred to the need for tracebacks to the source. Hagen’s laudable goals will be jettisoned if she is restrained by the agency’s current attitudes and policies. Will she survive guaranteed court battles involved with any agency attempt to reintroduce “hands on” inspection policies, utilize police action, and re-embrace meaningful command and control?

Hagen will quickly perceive that the agency unwittingly painted itself into a feckless corner when it concocted its HACCP Hoax, and is now paying the price, just like consumers who are being unnecessarily sickened largely because of agency lethargy.

However, we do have one jewel on which to hold, which may provide a glimpse into what the agency portends the future to be.

On Oct. 8, 2010, only one month ago, FSIS issued Notice 58-10, which requires inspectors to document all source origination information, at the time of sample collection, when he/she collects samples of ground beef or trim for microbial analysis at USDA labs. The fact that this procedure was not part and parcel of original FSIS HACCP protocol from day one reveals that the HACCP Hoax is far-removed from a scientific basis.

Past policy to delay such documentation until adverse lab findings are available is but one example of agency policies based in political science and science fiction, but not true science. Only time will tell if FSIS survives guaranteed litigation challenges to Notice 58-10, which flies against agency promises to maintain a “hands off” non-involvement role, to not police the industry, and to disband command and control.

Inspector documentation of source evidence, at the time of sample collection, is in bald-faced opposition to FSIS pre-HACCP promises. Does the agency
have authority, or does it not? Will the tail wag the dog? Better yet, which is the dog, and which is the tail? Who is on first here, FSIS or the industry?

Recently I benefitted from a timely discussion with a friend about Notice 58-10, and its pertinence to this discussion. My friend is a South African, and has been in the U.S. for 10 years. He and his wife were quite surprised when they became familiar with food recalls in the U.S., as they had never encountered food recalls in South Africa.

He explained how all private labs in South Africa, in every industry, are linked with government labs. The government labs can view all private lab results, in real time, in one integrated system. If such a system was suggested in the U.S., many industries would cry “foul,” and energize their lobbyists to strangle such heresy even before legislation were to be introduced.

Bottom line: FSIS regales in the deregulated meat non-inspection system known as USDA Style HACCP. The agency has semi-retired at the largest plants, via HACCP’s deregulation. Meanwhile, the agency has hyper-regulated the small plants, many of them out of existence.

Deregulation has insulated FSIS from delicately uncomfortable enforcement attempts against the big packers, who constitute a cozy future employer for agency employees subsequent to retirement from the agency. However, as with all fraudulent ruses, the predictable results of lack of meaningful agency oversight at the largest source slaughter plants has resulted in recurring recalls and outbreaks, which not even FSIS can cover up.

Deregulation of the banking/investment industry likewise resulted in difficulties that were bound to occur, and the agency’s inappropriate deregulation of the big packers is having similar results. FSIS has attempted to justify its HACCP ruse by painting it as “science based.” FSIS merely used its form of HACCP as a Trojan Horse to implement a more comfortable deregulation format.

The Federal Meat Inspection Act was intended to promote public health, not agency comfort.

Lastly, if the authors of S 510 and HR 2749 truly desire the production of safer products, they would be best advised to totally reject any similarity to USDA-style HACCP protocol. If these authors desire the destruction of small domestic food producers then, yes, they should emulate USDA-style HACCP. They will merely make the big food producers bigger, and eviscerate rural America of small producers, while increasing our reliance on imported food of questionable quality and safety.

USDA-style HACCP was originally described as a pathogen chase, but quickly degenerated into a paper chase. Industry behemoths have full-time staffs to play this paper chase game to perfection, while in reality they continue to ship pathogens into commerce, while our government hides behind the skirt of deregulation, fearful of litigation from large corporations and their associations.

FSIS successfully convinced America that its style of HACCP deregulation was science based, with obvious benefits for all. How much longer will America be willing to pay the price for this FSIS feint? Senators and representatives, consumer activists, and the media need to become cognizant of this intentional FSIS deception, which not only threatens public health, but also the viability of small American producers, who are being eliminated not because they cannot produce safe products, but because they cannot comply with the plethora of government and legislative mandates requiring mountains of costly and unnecessary paperwork.

I may only be one voice crying in the wilderness, but S 510 and HR 2749 have the potential for domestic disaster in the same realm as created by USDA’s HACCP Mega Reg.

We’d better get ready for a one-world government, because the rest of the globe will be providing our needs, and we’d better be in good stead with them.

Thanks, FSN, for publishing John Munsell’s long treatise on the important lessons in the Supreme Beef case.
There is absolutely no question about the accuracy of John’s final forecast of the devastating impact of the HACCP mega rule.
On 6-28-09 during the final push for HR 2749, Food and Water Watch published the 68 page “Where’s the Local Beef? Rebuilding Small-scale Meat Processing”
(http://www.foodandwaterwatch.org/food/action-alerts/wheres-the-local-beef-1/.) Appendix A: The Impact of HACCP on Small Plants begins on p. 37 and is 7 pages long.
Since, at least, 2001; the FDA has also known of the high initial implementation and continuing costs of HACCP-style food safety systems.
On 9-1-01, the FDA published a report the Institute of Food Technologists (IFT) had made for it entitled, “Analysis and Evaluation of Preventive Control Measures for the Control and Reduction/Elimination of Microbial Hazards on Fresh and Fresh-Cut Produce” (http://www.fda.gov/Food/ScienceResearch/ResearchAreas/SafePracticesforFoodProcesses/ucm090977.htm). It contains clearly written estimates showing the high cost of implementing HACCP-style food safety systems in fresh-cut produce.
Furthermore, on 3-1-06, the FDA issued its “Draft Guidance for Industry: Guide to Minimize food Safety Hazards of Fresh-Cut Fruits and Vegetables.” This time, the FDA grossly understated the estimates from the earlier, longstanding, never contradicted IFT study when it wrote, “Developing a HACCP plan is a onetime activity that is estimated to take 100 hours based on a trained HACCP team working on the plan full time.”
The FDA repeated this statement in the “Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables” recently reported upon by Cookson Beecher for FSN on 11-1-10 in “Produce Guidelines Urge, Don’t Require Compliance.” Ms. Beecher failed to mention this in her article.
For info on what a “trained HACCP team” is see “Assemble the HACCP Team.” It is reference #6 under “Additional Information” in “Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables” published February 2008—a predecessor to the guidance reported upon by Cookson Beecher.
“Assemble to HACCP Team” is from “Hazard Analysis and Critical Control Point Principles and Application Guidelines” (adopted August 14, 1997), NATIONAL ADVISORY COMMITTEE ON MICROBIOLOGICAL CRITERIA FOR FOODS (http://www.fda.gov/Food/FoodSafety/HazardAnalysisCriticalControlPointsHACCP/ucm114868.htm). This is report that supporters for S 510/HR 2749 cite as the scientific basis for its demand that all food facilities have HACCP-style plans.
Clearly, the HARPC plans that would be required under Sec. 103 of S 510 are beyond the financial ability of almost all of the small packers, processors and distributors in the local, healthy food movement. As scores of small meat processors before them, they would be forced to close by the industrial-size-only food safety regulations of S 510.

dangermaus

The government is never going to protect you from food poisoning. Learn to prepare your food safely. Try to buy your food directly from farmers whose beef doesn’t get co-mingled with everyone else’s.
It costs more, and takes more time, but what could improve your quality of life more than eating really, really well? What more practical exercise of personal art is there than cooking?
As more people start eating and living this way, the costs will come down, too!

L. E. Peterson

I’ve been involved in regulatory HACCP since the beginning and it’s degenerated into obsessing over things in the HACCP plan that may or may not have anything to do with the safety of the product. Inspectors have been reduced to nagging at the plants over typos in the plan, missing arrows in the flow charts, letters of guarantee, certificates of analysis and thermometer certifications. The agency is even telling plants what pathogens they have to address in their plans. It’s ridiculous and a these things are still no guarantee that the raw meat ingredients didn’t arrive contaminated from the source supplier.
The large plants will fight tooth and nail to keep inspectors from seeing their private test results even though salmonella, campylobacter and the like are directly related to food safety. They lawyered up as soon as the directive came out instructing us to look at the plant’s microbiological test results and told us it was proprietary information and we weren’t entitled to look at it. The only thing we can get our hands on in the big plants are the results that are dictated by regulation: The routine Lm samples and generic E. coli results. Then, all we can do is “advise” them that perhaps their sanitation measures and dressing procedures aren’t up to par. We can’t take action on it.
It’s frustrating as heck and then the inspectors take the fall when an outbreak gets traced back to their plant. I could retire early if I had a dime for everytime I’ve heard “how many postitive results and how many fecal zero tolerance NR’s do they have to have before we can shut them down?” out of inspectors in the big plants.

@Harry:
The report you cite is clear that the cost estimates are not for “small” facilities. Regardless, you go on to say that the more recent estimates from FDA are lower.
As we’ve gone over before, Section 103 states:
“‘‘(3) CONTENT.—The regulations promulgated under paragraph (1) shall—
‘‘(A) provide sufficient flexibility to be practicable for all sizes and types of facilities, including small businesses such as a small food processing facility co-located on a farm; ”
This is clearly intended to make sure the FDA does not require anything that will be overly burdensome from small facilities.
It goes on to say S.510 shall not “require a facility to hire a consultant or other third party to identify, implement, certify, or audit preventative controls”, which cuts out part of the FDA’s initial cost estimate anyways.
I think the point of Mr. Munsell’s article, and a good one at that, is that we need to be vigilant in order to make sure that FDA doesn’t use HARCP as an excuse to hand regulation over to the industry.

Thanks, FSN, for publishing John Munsell’s long treatise on the important lessons in the Supreme Beef case.
There is absolutely no question about the accuracy of John’s final forecast of the devastating impact of the HACCP mega rule.
On 6-28-09 during the final push for HR 2749, Food and Water Watch published the 68 page “Where’s the Local Beef? Rebuilding Small-scale Meat Processing”
(http://www.foodandwaterwatch.org/food/action-alerts/wheres-the-local-beef-1/.) Appendix A: The Impact of HACCP on Small Plants begins on p. 37 and is 7 pages long.
Since, at least, 2001; the FDA has also known of the high initial implementation and continuing costs of HACCP-style food safety systems.
On 9-1-01, the FDA published a report the Institute of Food Technologists (IFT) had made for it entitled, “Analysis and Evaluation of Preventive Control Measures for the Control and Reduction/Elimination of Microbial Hazards on Fresh and Fresh-Cut Produce” (http://www.fda.gov/Food/ScienceResearch/ResearchAreas/SafePracticesforFoodProcesses/ucm090977.htm). It contains clearly written estimates showing the high cost of implementing HACCP-style food safety systems in fresh-cut produce.
Furthermore, on 3-1-06, the FDA issued its “Draft Guidance for Industry: Guide to Minimize food Safety Hazards of Fresh-Cut Fruits and Vegetables.” This time, the FDA grossly understated the estimates from the earlier, longstanding, never contradicted IFT study when it wrote, “Developing a HACCP plan is a onetime activity that is estimated to take 100 hours based on a trained HACCP team working on the plan full time.”
The FDA repeated this statement in the “Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables” recently reported upon by Cookson Beecher for FSN on 11-1-10 in “Produce Guidelines Urge, Don’t Require Compliance.” Ms. Beecher failed to mention this in her article.
For info on what a “trained HACCP team” is see “Assemble the HACCP Team.” It is reference #6 under “Additional Information” in “Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables” published February 2008—a predecessor to the guidance reported upon by Cookson Beecher.
“Assemble to HACCP Team” is from “Hazard Analysis and Critical Control Point Principles and Application Guidelines” (adopted August 14, 1997), NATIONAL ADVISORY COMMITTEE ON MICROBIOLOGICAL CRITERIA FOR FOODS (http://www.fda.gov/Food/FoodSafety/HazardAnalysisCriticalControlPointsHACCP/ucm114868.htm). This is report that supporters for S 510/HR 2749 cite as the scientific basis for its demand that all food facilities have HACCP-style plans.
Clearly, the HARPC plans that would be required under Sec. 103 of S 510 are beyond the financial ability of almost all of the small packers, processors and distributors in the local, healthy food movement. As scores of small meat processors before them, they would be forced to close by the industrial-size-only food safety regulations of S 510.

USDA Inspector

I agree with some of the statements in this article. Want a solution to the food safety issues in our country? Stop mass producing animals in confinement and no more preventative antibiotics. That will never happen because humans put money before food safety and animal welfare.

Henry R. Lopez Ret. USDA Insp.

In the above cited case and in the many other cases involving E.Coli the down stream processor has always been the one that has been determined by the USDA to be at fault. This is the most erroneous concept in all meat inspection. It is the slaughter supplier to these plants for further processing who should bear the responsibility for any inherent pathogen, not the down stream processor. When will the USDA stop punishing the bearer of bad news and not the writer. As efficent and however clean these plants are it is of no consequence, it is the product which they recieve from slaughter that is the culprit.

Henry R. Lopez Ret. USDA Insp.

In the above cited case and in the many other cases involving E.Coli the down stream processor has always been the one that has been determined by the USDA to be at fault. This is the most erroneous concept in all meat inspection. It is the slaughter supplier to these plants for further processing who should bear the responsibility for any inherent pathogen, not the down stream processor. When will the USDA stop punishing the bearer of bad news and not the writer. As efficent and however clean these plants are it is of no consequence, it is the product which they recieve from slaughter that is the culprit.